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Insertion of article 8 in the Medicines (Pharmacy and General Sale—Exemption) Order 1980

5.  After article 7 of the Medicines (Pharmacy and General Sale-Exemption) Order 1980 (exemption for foods and cosmetics)(1) insert the following article—

“Exemption for the supply of medicines in the event, or anticipation, of pandemic disease

8.  The restrictions imposed by sections 52 and 53 (sale or supply of medicinal products) shall not apply to the supply of a medicinal product by a person where that supply is—

(a)made—

(i)whilst a disease is, or

(ii)in anticipation of a disease being imminently,

pandemic and a serious risk, or potentially a serious risk, to human health; and

(b)in accordance with a protocol which—

(i)is approved by—

(aa)the Ministers;

(bb)an NHS body (within the meaning of article 7A(4) of the Prescription Only Medicines (Human Use) Order 1997); or

(cc)the Health Protection Agency established under section 1 of the Health Protection Agency Act 2004; and

(ii)contains criteria as to—

(aa)symptoms of, and treatment for, that disease;

(bb)the recording of the name of the person who supplies the prescription only medicine to the person to be treated (or to a person acting on that person’s behalf) and of the evidence that the medicine was supplied to the person to be treated (or to a person acting on that person’s behalf.”.